Fluid specimen jars or cups are commonly used to collect and test fluid specimens for the presence or absence of specific “indicators,” which show the presence of specific chemicals, hormones, antibodies or antigens and are most commonly used for drug and pregnancy testing, among other types of assay tests.
Collecting and testing fluid specimens carries a measure of health risk for the person conducting the test and contamination risk to the specimen or testing media. Testing devices have previously required that a specimen be placed in a specimen cup and that a technician manually insert and submerge a portion of a testing strip into the specimen then, withdraw it to read the results. With the potential for contact with the sample by the technician and its associated health and contamination risks, a sealed receptacle for preventing contact is desirable. Various means have been proposed for further reducing the risk of contact as shown in U.S. Pat. No. 4,976,923 to Lipsky et al, and U.S. Pat. No. 5,429,804 to Sayles, which utilize a one-step testing device, with chromatographic testing strips mounted in their lids.
Others, as shown in U.S. Pat. No. 5,119,830 to Davis propose a test strip adhered to the floor of the lid, covered with a frangible surface which when punctured allows contact with the specimen when the device is inverted. A mylar-type sheet encasing the test strip and the frangible portion, defining the test space and preventing outside contact with the specimen during testing.
Other devices like U.S. Pat. No. 5,976,895 to Cipkowski, provide means for avoiding inversion. However, such devices are limited in that only a pre-determined amount of specimen can be tested. Overfilling encourages contact between specimen, and technician, either during insertion of the testing card, or when the technician opens the container to empty a portion of the contents. There can also be the difficulty of locating a proper place for discarding of the excess specimen. Also, if the maximum fluid level is exceeded, test results will not be reliable as the testing process may be adversely affected if the sample contacts the test strip higher than the sampling pad's limit line.
Often, medical device manufacturers, do not make products geared for use by the lay person, unless so targeted. Recently, the use of specimen testing devices by other than health care professionals has increased. Due to the fact that these tests are increasingly performed and evaluated by relatively unskilled technicians, the device needs to be relatively simple to operate to ensure adequate exposure of the test strip and provide accurate results. Devices that require inversion and subsequent righting of the container to conduct the test, involve certain measure of skill to provide adequate submersion of the test strips.
U.S. Pat. No. 5,403,551 to Galloway, requires inversion to an unspecified angle, making gauging adequate submersion of the test strips difficult and uncertain. Further, testing chambers that allow the flow of a fluid-specimen onto a test strip upon inversion, also allow the sample to escape upon righting, which can affect submersion of the test strip by trapping air-bubbles, which can inhibit the capillary movement of a specimen up a test strip. Since capillary action can be adversely affected by trapped air, and the position and orientation of the test strips. Devices which place the strips in a horizontal orientation, hinders capillary movement.
A “splash-shield” mechanism is shown by U.S. Pat. No. 5,429,804 to Sayles, to prevent secondary contact of the specimen with the test strip prior to the initial submersion to prevent premature testing of a specimen. In these devices, proper subjection of the test strip sampling pad to the specimen therefore requires a skill which may be beyond that of an inexperienced technician, resulting in unreliable and often inaccurate results. The splash-shield can also interfere with the submersion of the testing strip by trapping air-bubbles.
Since these tests are widely used in the medical industry, the workplace, athletic competitions and law enforcement. There is a need for being able to conduct various assay tests in large quantities. However, since testing materials are typically disposable, this can be costly. Testing devices are costly due to materials and difficulty in manufacturing, and are therefore not practical for use by certain organizations or institutions having limited resources.
Examples of complicated and thus costly testing devices are demonstrated by U.S. Pat. No. 5,403,551 to Galloway, et al and U.S. Pat. No. 5,976,895 to Cipkowski, both of which require multiple components, increasing materials and manufacturing cost. Both also require specially designed cartridges that are only compatible with a specific type of container.
Presently, test results are viewed by examining the test strip directly or through the testing device itself and manually recorded by a technician. Therefore, the results can be very subjective and without proof after the test strip has been saturated and/or discarded.
Therefore, there is a need to ensure proper testing, by allowing each strip to be in continuous, but controlled contact with the fluid sample, to orient the test strips in the most efficient position to maximize capillary movement of the specimen, and to vent or prevent air-bubbles, making the testing device easy to operate and produce more reliable results than previous testing devices.
The invention results from a need to reduce the above-mentioned deficiencies in the art.